Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries

Cesarean Section; Dehiscence Clinical Trial

Official title:

Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609281
• Other study ID #: Ayman CS Scar
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.

Description:

design and settings: This study is a descriptive, cross-sectional and multicenter study conducted at Tanta and Benha Universities, Egypt in the period from August, 1, 2018 to December, 31, 2018.

Patients:

Eligibility: Nine hundred patients were selected carefully according to inclusion and exclusion criteria. The inclusion criteria were: (i) Primipara having prior cesarean delivery whether scheduled or emergency (ii) Term delivery ≥ 37 weeks of gestation (iii) Multipara having the last delivery by cesarean either scheduled or emergency (iv) The interval following cesarean delivery to be 6 months at least and (v) Double-layer repair of uterus and (vi) Cesarean by pfannensteil incisions. The exclusion criteria were: (i) Repeat cesarean sections (ii) Preterm delivery (iii) Associated placental abnormalities (iv) Single-layer repair of uterus and (v) Refusal to participate.

Allocations: This study is not a clinical trial so allocation is made based on characteristics of patients and eligibility to be allocated in either scheduled cesarean group or emergency cesarean group. The allocation was not equal based on the percentage of patients in either group. The scheduled cesarean group included 580 cases while the emergency cesarean group included 320 cases from both universities.

Intervention: Cesarean scar assessment included both uterine scar and cutaneous scar. The uterine scar was assessed by transvaginal 3D ultrasound. The used device in both universities was DC-30 device of Mindray Company. All ultrasound examinations were conducted by third author in this study. Cutaneous scar was assessed by surgery department represented by the fourth author in this study. The uterine scar in both groups was examined for distance from internal os, length, thickness, volume, vasculature and presence of any defects. Cutaneous scar was examined for distance from symphysis pubis, length, shape, any depressed areas, any defects (hernia orifice), sinus and presence of keloid or hypertrophic scar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Primipara delivered by cs

• Multipara with last delivery by cs

• Full term delivery >37 weeks

• Double layer cesarean repair

• Pfannenstiel incison

Exclusion Criteria:

• Repeat cs

• Any placental abnormalities

• Preterm delivery

• Single layer cesarean repair

• Refusal to participate

Related Conditions & MeSH terms

• Cesarean Scar Niche
• Cesarean Section; Dehiscence
• Cesarean Wound; Dehiscence
• Emergencies

Intervention

Radiation:
• Ultrasound assessement of uterine scar
3D ultrasound assessment of scar characteristics

Locations

Country	Name	City	State
Egypt	Ayman Shehata Dawood	Tanta	Algharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar characteristics	Site of scar in relation to internal os of cervix	6 months
Primary	Scar length	length of scar in mm	6 months
Primary	thickness of scar	Scar depth in mm	6 months
Primary	Scar volume	Length multiplied by width multiplied by depth	6 months
Primary	Scar vascularity	Doppler on scar to assess vascularity	6 month
Secondary	Scar defect or niche	Assessment of scar weakness or scar defect by ultrasound with measurement of depth, width and length of defects plus the residual myometrial tissue	6 months